NCT05084287

Brief Summary

Evaluation of the reliability of the PEPPER robot in assisting and recording the parameters of a TM6. Patients referred to the EFRED service for the performance of a 6MWT will be assisted during their test by the PEPPER robot. The PEPPER robot will also collect the parameters of the 6MWT and produce a report. The EFRED service technician will remain present during the 6MWT and will take note of the test parameters. An evaluation of patient satisfaction with the assistance of the Robot Pepper in the realization of the 6MWT will also be carried out.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 19, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

October 4, 2021

Last Update Submit

March 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 6MWT parameters Robot vs Technician

    Measurement of the distance traveled by the patient compared to the measurement made by the medical technician

    1 day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

\- Patients referred for 6MWT to the EFRED department of the Pitié Salpêtrière hospital.

You may qualify if:

  • \>18 years
  • Speak fluent French.

You may not qualify if:

  • Patient's refusal to participate in the study
  • Language barrier
  • Cognitive disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP HP

Paris, France

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Central Study Contacts

Valery TROSINY DESERT, MD

CONTACT

Jacqueline DELRIEU, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 19, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations